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International Journal of Cardiology xxx (2012) xxx–xxx
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International Journal of Cardiology
journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Left ventricular partitioning device in a patient with chronic heart failure:
Short-term clinical follow-up
I. Bozdag-Turan a, 1, B. Bermaoui b, 1, R.G. Turan a, L. Paranskaya a, G. D`Ancona a, S. Kische a, K. Hauenstein b,
C.A. Nienaber a, H. Ince a,⁎
a
b
Department of Internal Medicine, Division of Cardiology, University Hospital Rostock, Rostock, Germany
Institute Diagnostic and Interventional Radiology, University of Rostock, Rostock, Germany
a r t i c l e
i n f o
Article history:
Received 17 June 2012
Accepted 24 June 2012
Available online xxxx
Keywords:
ParachuteTM ventricular partitioning device
anterior MI
ischemic heart failure
The increase in left ventricular (LV) volume after a myocardial infarction is a component of the remodelling process and it is associated
with a poor clinical outcome. Hence, the current management strategy
for ischemic LV dysfunction has been aimed to reverse the remodelling
process (i.e., reduction of LV volume and improved ejection fraction)
by medical therapy. Although major breakthroughs have been made
in the medical treatment of these patients, the LV remodelling and the
syndrome of heart failure continue to progress despite optimal medical
therapy. Therefore, a search for therapies with mechanisms of action
other than neurohormonal antagonism seems justified.
A novel heart catheter-based procedure has been developed. The
Parachute™ Ventricular Partitioning Device (Parachute™) is deployed
percutaneously in the left ventricle in patients with antero‐apical
regional wall motion abnormalities after a myocardial infarction (MI) to
partition the ventricle and segregate the dysfunctional region. This technique has been tested in experimental and small pilot studies where the
Parachute™ results were safe and effective in the short term. We present
in this case report with 3 and 6 month follow up of a patient implanted
with the Parachute™ after being screened according to echocardiographic and 3D Cardiac CT parameters.
A 68-year-old man with history of anterior MI and subsequent development of LV antero-apical wall motion abnormalities was admitted in our hospital. He reported dyspnoea on heavy exertion. His past
surgical history included coronary bypass surgery and ICD implantation. Clinically, the patient had refractory class II–III NYHA heart fail⁎ Corresponding author at: Department of Internal Medicine, Division of Cardiology,
Rostock-University, Ernst Heydemann Str 6, 18055 Rostock, Germany. Tel.: +49 381
4947794; fax: +49 381 4947798.
E-mail address: [email protected] (H. Ince).
1
Both authors contributed equally to this work.
ure despite aggressive medical treatment. ECG showed sinus rhythm
and a right bundle branch block with deep Q-waves (V1 to V6), elevated St-segments in V1 to V4 and terminal T-depression.
The patient was screened firstly according to echocardiographic
criteria: (I) EFb 40%, (II) LV dilatation (LVEDD>56 mm and LVESD>
38 mm), (III) antero‐apical regional wall motion abnormalities
(akinetic/dyskinetic), (IV) LV apex diameter (LVAD)=4.0×5.0 cm. Secondly, according to 3D-Cardiac-CT (LV architecture, geometry, and
trabeculation).
Echocardiography revealed a dilated LV (65 mm) with anteroapical wall motion abnormalities, no apical thrombus, and calculated
LV ejection fraction (EF) of 27% (by Simpson biplane formula). End
systolic volume index (ESVI) was 76.8 mL/m 2. LVAD was (4.5× 5 cm)
(Fig. 1A). A 3D Cardiac-CT demonstrated an appropriate architecture
and geometry with trabeculation of the LV (Fig. 2A). To determine the
functional status we assessed NYHA classification and the standard
6 min walk test by two independent and blinded cardiologist before
and 3 months after device implantation. Additionally, testing of the
change in quality of life was performed using Minnesota Living with
Heart Failure Questionnaire. Potential active coronary ischemia was
ruled out by coronary angiography.
The first experience in the world with a percutaneous implantation of a short foot Parachute™ was uneventful. The implantation
was performed under local anaesthesia via the right femoral artery.
The collapsed implant was attached to the delivery catheter, and advanced retrogradely through the guide catheter across the aortic valve
and positioned in the LV apex. A echocardiography was performed to
assess the appropriate positioning. The device was expanded using
compliant balloon dilatation.
A control echocardiography demonstrated that the Parachute™
was positioned at the apex, with no residual leak between the walls
of the LV and the device. LV end-diastolic pressure decreased immediately from 16 to 12 mmHg. The total procedure time was 62 min,
and fluoroscopy time was 10 min. The post-implantation course was
uneventful, and the patient was discharged after 2 days. The patient
was discharged on aspirin, fosinopril, carvedilol, hydrochlorothiazide,
and simvastatin, with the addition of low-dose warfarin (target international normalized ratio of 2.0) for 3 months.
There was an increase of global LVEF, whereas a decrease of
LVEDV and LVESV at 3 and 6 months after the Parachute™ implantation as compared to baseline. Moreover, we found decrease of NYHA
class and NT-ProBNP 3 and 6 months after implantation compared to
0167-5273/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ijcard.2012.06.130
Please cite this article as: Bozdag-Turan I, et al, Left ventricular partitioning device in a patient with chronic heart failure: Short-term clinical
follow-up, Int J Cardiol (2012), doi:10.1016/j.ijcard.2012.06.130
e2
I. Bozdag-Turan et al. / International Journal of Cardiology xxx (2012) xxx–xxx
Fig. 1. (A) LV dilatation with antero‐apical wall motion abnormalities in transthoracal echocardiography (pre parachute implantation). (B) Parachute device in two chamber view in
TEE (post‐parachute implantation).
baseline. Furthermore, a significant improvement of 6 min walk test
and quality of life were observed 3 and 6 months after device implantation compared to baseline (Table 1).
On discharge and 3 months after the Parachute™ implantation control echocardiographic and 3D-Cardiac-CT examinations showed that
implant was in good position and there was no leakage between static
and dynamic LV chamber (Figs. 1B and 2B). ECG at rest, on exercise,
and 24-h Holter ECG revealed no rhythm disturbances at any time
point. There was no inflammatory response or myocardial reaction
(white blood cell count, CRP, CPK) on discharge, and 3–6 months after
the Parachute™ implantation. Serum creatinine and blood urea nitrogen
did not show changes at 24 h following procedure or at discharge compared to baseline values.
Although several surgical approaches have been advocated in patients with dilated LV, including partial left ventriculectomy (Batista
procedure), cardiomyoplasty, and surgical ventricular remodelling
(Dor procedure), only the latter is frequently used with acceptable
short and long-term effects on mortality and morbidity. Perioperative mortality is still higher than 5%, and the overall 5-year survival
is less than 70%.
The Parachute™ is delivered percutaneously from the femoral artery
using standard techniques for left heart catheterization without open
heart surgery. Pre-clinical studies in an animal model of MI have demonstrated that the Parachute™ implant has beneficial effects on cardiac
function [1]. In a recently published clinical pilot study, the implant
was successfully implanted in 15 of 18 (83%) patients with significant
favourable effect on LV function [2].
In this case report we discuss, for the first time, a screening procedure
including echocardiographic and 3D Cardiac-CT, before implantation.
The same methodology can be employed at follow-up. We confirm an
improvement in LVEF% and clinical status, as proposed by Sagic et al.
[2]. Moreover, we report an improvement in quality of life and
NT-ProBNP values 3 and 6 months after implantation.
In conclusion, the combination between percutaneous LV volume reduction by the Parachute™ implantation and standard medical therapy
may be an important option to consider in the treatment of patients
with antero‐apical wall motion abnormalities. Moreover, there is a need
for adequate screening of potential candidates for the Parachute™ implantation. In this context, specific echocardiographic and 3D-Cardio-CT
criteria may serve as tools for a timely selection of candidates.
Please cite this article as: Bozdag-Turan I, et al, Left ventricular partitioning device in a patient with chronic heart failure: Short-term clinical
follow-up, Int J Cardiol (2012), doi:10.1016/j.ijcard.2012.06.130
I. Bozdag-Turan et al. / International Journal of Cardiology xxx (2012) xxx–xxx
e3
Fig. 2. (A) LV dilatation with antero‐apical regional wall motion abnormalities (pre‐parachute implantation. (B) Parachute device (post‐parachute implantation) in 3D cardiac CT.
Table 1
Cardiac function, clinical functional status parameters at baseline, 3 and 6 months after
Parachute™ implantation.
LVEF (%)
LVEDV (ml)
LVESV (ml)
NYHA classification
NT-ProBNP (pg/ml)
6 min walk test (m)
Quality of Life
Baseline
3 months after
Parachute™
implantation
6 months after
Parachute™
implantation
27
220
154
III
850
220
29
33
190
131
I-II
620
800
12
34
185
132
I-II
625
980
11
Global left ventricular ejection fraction (LVEF), end-diastolic volume (LVEDV), endsystolic volume (LVESV), New York Heart Association (NYHA), N-terminal pro brain
natriuretic peptide (NT-ProBNP).
Acknowledgments
The authors of this manuscript have certified that they comply
with the Principles of Ethical Publishing in the International Journal
of Cardiology [3].
References
[1] Nikolic S, Khairkhahan A, Ryu M, Champsaur G, Breznock E, Dae M. Percutaneous
implantation of an intraventricular device for the treatment of heart failure: experimental results and proof of concept. J Card Fail 2009;15:790–7.
[2] Sagic D, Otasevic P, Sievert H, Elsasser A, Mitrovic V, Gradinac S. Percutaneous
implantation of the left ventricular partitioning device for chronic heart failure: a
pilot study with 1-year follow-up. Eur J Heart Fail 2010;6:600–6.
[3] Coats AJS, Shewan LG. Ethics in the authorship and publishing of scientific articles.
Int J Cardiol 2011;153:239–40, doi:10.1016/j.ijcard.2011.10.119.
Please cite this article as: Bozdag-Turan I, et al, Left ventricular partitioning device in a patient with chronic heart failure: Short-term clinical
follow-up, Int J Cardiol (2012), doi:10.1016/j.ijcard.2012.06.130